ZALURON XL 150 MG PROLONGED-RELEASE TABLETS

Transcript

Package leaflet: Information for the user
Zaluron XL 50 mg, 150 mg, 200 mg, 300 mg,
400 mg prolonged-release tablets
Quetiapine
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Zaluron XL is and what it is used for
2. What you need to know before you take Zaluron
XL
3. How to take Zaluron XL
4. Possible side effects
5. How to store Zaluron XL
6. Contents of the pack and other information
1. What Zaluron XL is and what it is used for
Zaluron XL contains a substance called quetiapine.
This belongs to a group of medicines called antipsychotics. Zaluron XL can be used to treat several
illnesses, such as:
• Bipolar depression and major depressive episodes
in major depressive disorder: where you feel sad.
You may find that you feel depressed, feel guilty,
lack energy, lose your appetite or can’t sleep.
• Mania: where you may feel very excited, elated,
agitated, enthusiastic or hyperactive or have poor
judgment including being aggressive or disruptive.
• Schizophrenia: where you may hear or feel things
that are not there, believe things that are not true
or feel unusually suspicious, anxious, confused,
guilty, tense or depressed.
When Zaluron XL is being taken to treat major
depressive episodes in major depressive disorder, it
will be taken in addition to another medicine being
used to treat this illness.
Your doctor may continue to prescribe Zaluron XL
even when you are feeling better.
2. What you need to know before you take
Zaluron XL
Do not take Zaluron XL
• If you are allergic to quetiapine or any of the other
ingredients of this medicine (listed in section 6)
• If you are taking any of the following medicines:
- some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression)
Do not take Zaluron XL if the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Zaluron XL.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Zaluron XL if:
• You, or someone in your family, have or have
had any heart problems, for example heart rhythm
problems, weakening of the heart muscle or
inflammation of the heart or if you are taking any
medicines that may have an impact on the way your
heart beats.
• You have low blood pressure.
• You have had a stroke, especially if you are
elderly.
• You have problems with your liver.
• You have ever had a fit (seizure).
• You have diabetes or have a risk of getting
diabetes. If you do, your doctor may check your
blood sugar levels while you are taking Zaluron XL.
• You know that you have had low levels of white
blood cells in the past (which may or may not have
been caused by other medicines).
• You are an elderly person with dementia (loss of
brain function). If you are, Zaluron XL should not be
taken because the group of medicines that Zaluron
XL belongs to may increase the risk of stroke, or in
some cases the risk of death, in elderly people with
dementia.
• You or someone else in your family has a history
of blood clots, as medicines like these have been
associated with formation of blood clots.
• You have or have had a condition where you stop
breathing for short periods during your normal
nightly sleep (called “sleep apnoea”) and are taking
medicines that slow down the normal activity of the
brain (“depressants”).
• You have or have had a condition where you
can’t completely empty your bladder (urinary
retention), have an enlarged prostate, a blockage
in your intestines, or increased pressure inside your
eye. These conditions are sometimes caused by
medicines (called “anti-cholinergics”) that affect the
way nerve cells function in order to treat certain
medical conditions.
• You have or have had problems with alcohol or
drug abuse.
Tell your doctor immediately if you
experience any of the following after taking
Zaluron XL:
• A combination of fever, severe muscle stiffness,
sweating or a lowered level of consciousness (a
disorder called “neuroleptic malignant syndrome”).
Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or
tongue.
• Dizziness or a severe sense of feeling sleepy. This
could increase the risk of accidental injury (fall) in
elderly patients.
• Fits (seizures).
• A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of
medicine.
Tell your doctor as soon as possible if you have:
• A fever, flu-like symptoms, sore throat, or any
other infection, as this could be a result of a very
low white blood cell count, which may require
Zaluron XL to be stopped and/or treatment to be
given.
• Constipation along with persistent abdominal
pain, or constipation which has not responded
to treatment, as this may lead to a more serious
blockage of the bowel.
Thoughts of suicide and worsening of your
depression
If you are depressed you may sometimes have
thoughts of harming or killing yourself. These may
be increased when first starting treatment, since
these medicines all take time to work, usually about
two weeks but sometimes longer.
These thoughts may also be increased if you
suddenly stop taking your medication. You may
be more likely to think like this if you are a young
adult. Information from clinical trials has shown an
increased risk of suicidal thoughts and/or suicidal
behaviour in young adults aged less than 25 years
with depression.
If you have thoughts of harming or killing yourself
at any time, contact your doctor or go to a hospital
straight away. You may find it helpful to tell a
relative or close friend that you are depressed, and
ask them to read this leaflet. You might ask them
to tell you if they think your depression is getting
worse, or if they are worried about changes in your
behaviour.
Weight gain
Weight gain has been seen in patients taking
Zaluron XL. You and your doctor should check your
weight regularly.
Children and adolescents
Zaluron XL is not for use in children and adolescents
below 18 years of age.
Other medicines and Zaluron XL
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
Do not take Zaluron XL if you are taking any of the
following medicines:
• Some medicines for HIV.
• Azole medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell your doctor if you are taking any of the
following medicines:
• Epilepsy medicines (like phenytoin or
carbamazepine).
• High blood pressure medicines.
• Barbiturates (for difficulty sleeping).
• Thioridazine or Lithium (other anti-psychotic
medicines).
• Medicines that have an impact on the way your
heart beats, for example, medicines that can cause
an imbalance in electrolytes (low levels of potassium
or magnesium) such as diuretics (water pills) or
certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called “anti-cholinergics”) that affect
the way nerve cells function in order to treat certain
medical conditions.
Before you stop taking any of your medicines,
please talk to your doctor first.
Zaluron XL with food, drink and alcohol
• Zaluron XL can be affected by food and you should
therefore take your tablets at least one hour before
a meal or prior to bedtime.
• Be careful how much alcohol you drink. This is
because the combined effect of Zaluron XL and
alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking
Zaluron XL. It can affect the way the medicine
works.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine.
You should not take Zaluron XL during pregnancy
unless this has been discussed with your doctor.
Zaluron XL should not be taken if you are breastfeeding.
The following symptoms which can represent
withdrawal may occur in newborn babies, of
mothers that have used Zaluron XL in the last
trimester (last three months of their pregnancy):
shaking, muscle stiffness and/or weakness,
sleepiness, agitation, breathing problems, and
difficulty in feeding. If your baby develops any of
these symptoms you may need to contact your
doctor.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive
or use any tools or machines until you know how
the tablets affect you.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking
Zaluron XL may cause positive results for
methadone or certain drugs for depression called
tricyclic antidepressants (TCAs) when some test
methods are used, even though you may not be
taking methadone or TCAs. If this happens, a more
specific test can be performed.
Zaluron XL contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. How to take Zaluron XL
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
Your doctor will decide on your starting dose. The
maintenance dose (daily dose) will depend on your
illness and needs but will usually be between 150
mg and 800 mg.
• You will take your tablets once a day.
• Do not split, chew or crush the tablets.
• Swallow your tablets whole with a drink of water.
• Take your tablets without food (at least one hour
before a meal or at bedtime, your doctor will tell
you when).
• Do not drink grapefruit juice while you are taking
Zaluron XL. It can affect the way the medicine
works.
• Do not stop taking your tablets even if you feel
better, unless your doctor tells you to.
Liver problems
If you have liver problems your doctor may change
your dose.
Elderly people
If you are elderly your doctor may change your
dose.
Use in children and adolescents
Zaluron XL should not be used by children and
adolescents aged under 18 years.
If you take more Zaluron XL than you should
If you take more Zaluron XL than prescribed by
your doctor, you may feel sleepy, feel dizzy and
experience abnormal heart beats. Contact your
doctor or nearest hospital straight away. Take the
Zaluron XL tablets with you.
If you forget to take Zaluron XL
If you forget to take a dose, take it as soon as you
remember. If it is almost time to take the next dose,
wait until then. Do not take a double dose to make
up for a forgotten tablet.
If you stop taking Zaluron XL
If you suddenly stop taking Zaluron XL, you may
be unable to sleep (insomnia), or you may feel
sick (nausea), or you may experience headache,
diarrhoea, being sick (vomiting), dizziness or
irritability.
Your doctor may suggest you reduce the dose
gradually before stopping treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Very common (may affect more than 1 in 10
people):
• Dizziness (may lead to falls), headache, dry
mouth.
• Feeling sleepy (this may go away with time, as
you keep taking Zaluron XL) (may lead to falls).
• Discontinuation symptoms (symptoms which occur
when you stop taking Zaluron XL) include not being
able to sleep (insomnia), feeling sick (nausea),
headache, diarrhoea, being sick (vomiting),
dizziness and irritability. Gradual withdrawal over a
period of at least 1 to 2 weeks is advisable.
• Putting on weight.
• Abnormal muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats
(triglycerides and total cholesterol)
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has
skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing up. This may
make you feel dizzy or faint (may lead to falls).
• Increased levels of sugar in the blood.
• Blurred vision
• Abnormal dreams and nightmares
• Feeling more hungry
• Feeling irritated
• Disturbance in speech and language
• Thoughts of suicide and worsening of your
depression
• Shortness of breath
• Vomiting (mainly in the elderly)
• Fever
• Changes in the amount of thyroid hormones in
your blood
• Decreases in the number of certain types of blood
cells
• Increases in the amount of liver enzymes
measured in the blood
• Increases in the amount of the hormone prolactin
in the blood. Increases in the hormone prolactin
could in rare cases lead to the following:
o Men and women to have swelling of breasts and
unexpectedly produce breast milk.
o Women to have no monthly period or irregular
periods.

Job No.

22319

Original Filename

ZaluronXL_PIL_v3.0

Version Reference

d / PIL_429240007_v3

Date of Amendment

15/07/2016

Sign off Date

Uncommon (may affect up to 1 in 100 people):
• Fits or seizures
• Allergic reactions that may include raised lumps
(weals), swelling of the skin and swelling around
the mouth.
• Unpleasant sensation in the legs (also called
restless legs syndrome).
• Difficulty swallowing
• Uncontrollable movements, mainly of your face or
tongue.
• Sexual dysfunction.
• Diabetes.
• Change in electrical activity of the heart seen on
ECG (QT prolongation)
• A slower than normal heart rate which may
occur when starting treatment and which may be
associated with low blood pressure and fainting.
• Difficulty in passing urine.
• Fainting (may lead to falls)
• Stuffy nose
• Decrease in the amount of red blood cells
• Decrease in the amount of sodium in the blood
• Worsening of pre-existing diabetes.
Rare (may affect up to 1 in 1,000 people):
• A combination of high temperature (fever),
sweating, stiff muscles, feeling very drowsy or
faint (a disorder called “neuroleptic malignant
syndrome).”
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis)
• A long-lasting and painful erection (priapism).
• Swelling of breasts and unexpected production of
breast milk (galactorrhoea).
• Menstrual disorder.
• Blood clots in the veins especially in the legs
(symptoms include swelling, pain and redness in the
leg), which may travel through blood vessels to the
lungs causing chest pain and difficulty in breathing.
If you notice any of these symptoms seek medical
advice immediately.
• Walking, talking, eating or other activities while
you are asleep.
• Body temperature decreased (hypothermia).
• Inflammation of the pancreas
• A condition (called “metabolic syndrome”) where
you may have a combination of 3 or more of
the following: an increase in the fat around your
abdomen, a decrease in “good cholesterol” (HDL
C), an increase in a type of fat in your blood called
triglycerides, high blood pressure and an increase in
your blood sugar.
• Combination of fever, flu-like symptoms, sore
throat, or any other infection with very low white
blood cell count, a condition called agranulocytosis.
• Bowel obstruction.
• Increased blood creatine phosphokinase (a
substance from muscles)
Very rare (may affect up to 1 in 10,000 people):
• Severe rash, blisters, or red patches on the skin.
• A severe allergic reaction (called anaphylaxis)
which may cause difficulty in breathing or shock.
• Rapid swelling of the skin, usually around the
eyes, lips and throat (angioedema).
• A serious blistering condition of the skin, mouth,
eyes and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that
controls urine volume.
• Breakdown of muscle fibers and pain in muscles
(rhabdomyolysis).

Not known (frequency cannot be estimated from
the available data):
• Skin rash with irregular red spots (erythema
multiforme)
• Serious, sudden allergic reaction with symptoms
such as fever and blisters on the skin and peeling of
the skin (toxic epidermal necrolysis)
• Symptoms of withdrawal may occur in newborn
babies of mothers that have used quetiapine during
their pregnancy.
The class of medicines to which Zaluron XL belongs
can cause heart rhythm problems, which can be
serious and in severe cases fatal.
Some side effects are only seen when a blood test
is taken. These include changes in the amount of
certain fats (triglycerides and total cholesterol)
or sugar in the blood, changes in the amount of
thyroid hormones in your blood, increased liver
enzymes, decreases in the number of certain types
of blood cells, decrease in the amount of red blood
cells, increased blood creatine phosphokinase (a
substance in the muscles), decrease in the amount
of sodium in the blood, and increases in the amount
of the hormone prolactin in the blood. Increases in
the hormone prolactin could in rare cases lead to
the following:
• Men and women to have swelling of breasts and
unexpectedly produce breast milk.
• Women to have no monthly period or irregular
periods.
Your doctor may ask you to have blood tests from
time to time.
Side effects in children and adolescents
The same side effects that may occur in adults may
also occur in children and adolescents.
The following side effects have been seen more
often in children and adolescents or have not been
seen in adults:
Very Common (may affect more than 1 in 10
people):
• Increase in the amount of a hormone called
prolactin, in the blood. Increases in the hormone
prolactin could in rare cases lead to the following:
- Boys and girls to have swelling of breasts and
unexpectedly produce breast milk
- Girls to have no monthly period or irregular
periods
• Increased appetite
• Vomiting
• Abnormal muscle movements. These include
difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Increase in blood pressure
Common (may affect up to 1 in 10 people):
• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side
effects you can help provide more information on
the safety of this medicine.
5. How to store Zaluron XL
Keep this medicine out of the sight and reach of
children.
Do not use this medicine Zaluron XL after the expiry
date which is stated on the container after EXP. The
expiry date refers to the last day of that month.
Zaluron XL does not require any special storage
conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment
6. Contents of the pack and other information
What Zaluron XL contains
• The active substance is quetiapine. Zaluron XL
tablets contain 50 mg, 150 mg, 200 mg, 300 mg or
400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: lactose anhydrous, Methacrylic acid –
ethyl acrylate copolymer (1:1), type A crystalline
maltose, magnesium stearate and talc.
Tablet coating: Methacrylic acid – ethyl acrylate
copolymer (1:1), type A, triethyl citrate.
What Zaluron XL looks like and contents of
the pack
- The 50 mg prolonged-release tablets are white
to off white, round biconvex, engraved with ‘50’
on one side, 7.1 mm in diameter and 3.2 mm in
thickness.
- The 150 mg prolonged-release tablets are white to
off white, oblong biconvex and engraved with ‘150’
on one side, 13.6 mm in length, 6.6 mm in width
and 4.2 mm in thickness.
2815084/2

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.